FDA Approves Zecuity Transdermal Patch for Migraine

The Food and Drug Administration (FDA) has approved Zecuity, a transdermal patch, for the treatment of migraines with or without auras. The single-use, battery-powered patch is applied to the skin and delivers a dose of sumatriptan, a synthetic drug used to treat migraine headaches. The patch also helps relieve migraine-related nausea.

According to Medscape, of the 16 million adults in the United States that have been diagnosed with migraine, half have migraine-related nausea (MRN) and usually avoid the use of oral medications.

Dr. Lawrence C. Newman, director of the Headache Institute at St. Luke’s-Roosevelt Hospital in New York, said:

“For these patients [with MRN], physicians need to assess and offer treatments tailored to each individual patient’s array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraineurs who experience nausea or vomiting as significant symptoms.”

The Zecuity patch is applied to the upper arm or thigh during a migraine. When the migraine sufferer pushes the button, the patch delivers 6.5 mg of sumatriptan throughout a four-hour dosing period.

Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center in Philadelphia, said, “[MRN] can be as debilitating as migraine headache pain itself. Treatments bypassing the GI tract may be the best way to treat these patients.”

In a phase 3 trial, 18 percent of patients receiving the active patch experienced resolved headache pain at two hours of the dosing period, compared to only 9 percent of those who received a placebo. During the headache resolution period, pain is lessened, but it is replaced by irritability or fatigue.

At two hours, 53 percent of patients receiving active treatment experienced headache pain relief, compared to 29 percent of those receiving a placebo. During that same time period, patients experienced relief from nausea at 84 percent and 63 percent respectively.

As we have recently reported, migraines with aura have been linked to heart disease in women. Migraines with aura have also been known to increase the possibility of a stroke. However, a definitive cause for the link between migraines with auras and heart disease has yet to be identified.